Dumping SyndromePhase 2NCT01637272
Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome
A Phase 2 study testing SOM230 in people with Dumping Syndrome, run by Novartis Pharmaceuticals at 17 sites in 5 countries.
Trial summary
multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dumping Syndrome
- What is being tested?
- SOM230
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 8 Jan 2013to 7 Aug 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years of age.
- Post-gastric or esophageal bypass surgery, matching one of the criteria below:
- Bariatric surgery: more than 6 months before signing the informed consent
- Esophageal cancer surgery: were disease free at study entry
- Gastric cancer surgery: were at stage 0 or I and were disease free at study entry
- Patient with a documented diagnosis of Dumping Syndrome defined as having:
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- History of/or active symptoms associated with dumping syndrome (e.g. post-prandial tachycardia, bloating, diarrhea) and
- Documented history of hypoglycemia based on either:
- glucose <50 mg/dL or 2.8 mmol/L on a sporadic or scheduled blood analysis -or
- glucose value <60 mg/dL or ≤ 3.3 mmol/L at 90, 120, 150 or 180 min during an OGTT
- Patients had at least one glucose level <60 mg/dL (or ≤ 3.3 mmol/L) at 90, 120, 150 or 180 min during the 3-hour OGTT at screening.
- Patients with esophageal cancer with a negative computed tomography (CT) or Magnetic resonance imaging (MRI) scan (neck, thoracic, and upper abdominal) and albumin
- ≥ 3.5 g/dl at baseline.
- Patients with gastric cancer with a negative CT or MRI scan (total abdomen).
- Karnofsky Performance Status ≥ 60 (i.e. required occasional assistance, but was able to care for most of their personal needs)
- Patients who received other therapies for dumping syndrome (such as acarbose, gama guar, pectin) must have stopped all treatments and had a wash out period prior to signing the informed consent (i.e. at least 2 weeks between last previous therapy and first dose of study medication in this study).
- Patients who had provided signed written informed consent prior to study participation.
Who cannot join
- Bariatric patients who had lap band.
- Patients with a current diagnosis of diabetes mellitus.
- Patients who had failed treatment with somatostatin analogues for dumping syndrome in the past.
- Patients who had been treated with somatostatin analogues in the past, must have had an appropriate interval between the last administration of somatostatin analogues treatment and the study drug as follows
- Octreotide sc for ≥ 72 hours
- Octreotide LAR for ≥ 56 days (8 weeks)
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- Lanreotide Autogel for ≥ 98 days (14 weeks)
- Lanreotide SR ≥ 28 days (4 weeks)
- Patients who were already treated with pasireotide.
- Patients who had a known hypersensitivity to somatostatin analogues.
- Patients who were receiving anti-cancer therapy (chemotherapy and/or radiotherapy).
- Patients who had any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
- Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test result (ELISA and Western blot). An HIV test was not required; however, previous medical history was reviewed.
- Non-malignant medical illnesses that were uncontrolled or whose control may have been jeopardized by the treatment with this study treatment.
- Life-threatening autoimmune and ischemic disorders.
- Patients with the presence of active or suspected acute or chronic uncontrolled infection.
- Inadequate end organ function as defined by:
- Inadequate bone marrow function:
- White blood cells (WBC) <2.5 x 109/L
- Absolute neutrophil count <1.5 x 109/L
- Platelets <100 x 109/L
- Hemoglobin <9 g/dL
- International normalized ratio (INR) ≥ 1.3
- Serum creatinine >2.0 mg/dL
- Alkaline phosphatase (ALP) >2.5 x upper limit of normal (ULN)
- Serum total bilirubin >1.5 x ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 x ULN
- History of liver disease, such as cirrhosis or chronic active hepatitis B and C.
- Presence of Hepatitis B surface antigen (HbsAg) and/ or presence of Hepatitis C antibody test (anti-Hepatitis C Virus).
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States6 sites
Virginia Endocrinology Research SC
Chesapeake, Virginia, 23321
Texas Tech University Health Science Center
El Paso, Texas, 79905
Ximed Center for Weight Management Ximed Research
La Jolla, California, 92037
Mayo Clinic - Rochester Mayo MN
Rochester, Minnesota, 55905
Stanford University Medical Center SC - SOM230X2203
Stanford, California, 94304
Montefiore Medical Center CLCZ696B2320
The Bronx, New York, 10467
Belgium4 sites
Novartis Investigative Site
Bruges, Belgium, 8310
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Leuven, 3000
France3 sites
Novartis Investigative Site
Paris, 75651
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Pierre-Bénite, 69495
Germany2 sites
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Würzburg, 97080
Netherlands2 sites
Novartis Investigative Site
Groningen, 9713 GZ
Novartis Investigative Site
Utrecht, Netherlands, 3584CX
About this study
Official title: A Multi-center, Intra-patient Dose Escalation Phase II Study to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients With Dumping Syndrome
multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome
Read the detailed description
43 adult patients with dumping syndrome received pasireotide s.c. during the dose escalation phase (3 months dose could be increased based on the presence of hypoglycemia during OGTT). After completing Month 3, patients were switched to pasireotide LAR for 3 months (up to Month 6). The core phase of the study was completed at the end of Month 6. Patients were allowed to enter the 6 month extension phase if they experienced benefit with pasireotide LAR treatment.
- Conditions
- Dumping Syndrome
- Being tested
- SOM230
- Keywords
- Dumping syndrome, SOM230, pasireotide LAR
- Medical subject headings
- Dumping Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOM230Drug
Also called pasireotide
Pasireotide (SOM230) sc injection was provided as solution for injection in individual 1-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide (as free base). Doses: 50, 100, 150 and 200 μg. Pasireotide im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 \& 60 mg of pasireotide (as free base) \& solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles. Doses: 10, 20, 30, 40 or 60 mg
| Study group | Role | What they receive |
|---|---|---|
| SOM230 | Experimental | Subjects with dumping syndrome treated with pasireotide Receives: Drug: SOM230 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate in Plasma Glucose Level
Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase
Measured: at Month 3 (M3)
Secondary outcomes (18)
Response Rate in Plasma Glucose Level
Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)
Measured: at Month 6 (M6), Month 12 (M12)
Response Rate in Pulse Rate
Pulse rate was defined as percentage of patients with change in pulse rate >=10 bpm from pre-OGTT to 30 minutes post OGTT.
Measured: at baseline, M3, M6, M12
Response Rate in Hematocrit Levels
Percentage of patients with change in hematocrit >= 3% from pre-OGTT to 30 minutes post OGTT.
Measured: M3, M6, M12
Insulin Levels During OGTT
Absolute insulin levels at the end of M3, M6, M12
Measured: M3, M6, M12
Glucagon Levels During OGTT
Absolute glucagon levels at the end of Months 3, 6 \& 12
Measured: M3, M6, M12
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
Absolute Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.
Measured: M3, M6, M12
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
Absolute Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.
Measured: M3, M6, M12
Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)
Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Measured: M3, M6, M12
Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
Absolute Dumping Severity Score (DSS) scores at end of M3, M6 \& M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early \& late scores. DSS Range (min (absent) - max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.
Measured: M3, M6, M8
Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 \& 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early \& late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early \& late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) - max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.
Measured: M3, M6, M12
Patient Global Assessment at the End of Months 3, 6 and 12
Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question: "Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study" .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better).
Measured: M3, M6, M12
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values
Measured: M1 to M3
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Measured: M1 to M3
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Measured: M1 to M3
Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)
Measured: M4 to M6
Summary of LAR PK Parameters by Dose
Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)
Measured: M4 to M6
Pasireotide Concentrations in LAR Phase
Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)
Measured: M7 to M12
LAR PK Parameter: Ctrough - at Steady State (ss) by Dose
In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.
Measured: M4 to M12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study start8 Jan 2013
- Primary completion7 Aug 2015
- Study completion7 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dumping SyndromeStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637272
- Sponsor's protocol ID
- CSOM230X2203
- Other IDs
- 2012-001534-34
- Status last verified
- Mar 2017
- First submitted
- 9 May 2012
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Intra-patient Dose Escalation Phase II Study to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients With Dumping Syndrome
- ClinicalTrials.gov ID
- NCT01637272
- Acronym / sponsor ID
- CSOM230X2203
- Conditions
- Dumping Syndrome
- Keywords
- Dumping syndrome, SOM230, pasireotide LAR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2013 (actual)
- Primary completion
- 7 Aug 2015 (actual)
- Study completion
- 7 Aug 2015 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Posted 10 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome
Detailed description
43 adult patients with dumping syndrome received pasireotide s.c. during the dose escalation phase (3 months dose could be increased based on the presence of hypoglycemia during OGTT). After completing Month 3, patients were switched to pasireotide LAR for 3 months (up to Month 6). The core phase of the study was completed at the end of Month 6. Patients were allowed to enter the 6 month extension phase if they experienced benefit with pasireotide LAR treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOM230 | Experimental | Drug: SOM230Subjects with dumping syndrome treated with pasireotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female patients ≥ 18 years of age.
- Post-gastric or esophageal bypass surgery, matching one of the criteria below:
- Bariatric surgery: more than 6 months before signing the informed consent
- Esophageal cancer surgery: were disease free at study entry
- Gastric cancer surgery: were at stage 0 or I and were disease free at study entry
Key exclusion criteria (29 listed)
- Bariatric patients who had lap band.
- Patients with a current diagnosis of diabetes mellitus.
- Patients who had failed treatment with somatostatin analogues for dumping syndrome in the past.
- Patients who had been treated with somatostatin analogues in the past, must have had an appropriate interval between the last administration of somatostatin analogues treatment and the study drug as follows
- Octreotide sc for ≥ 72 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOM230Also: pasireotidePasireotide (SOM230) sc injection was provided as solution for injection in individual 1-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide (as free base). Doses: 50, 100, 150 and 200 μg. Pasireotide im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 \& 60 mg of pasireotide (as free base) \& solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles. Doses: 10, 20, 30, 40 or 60 mg | Drug | SOM230 |
Primary outcome
Response Rate in Plasma Glucose Level
Time frame: at Month 3 (M3)
Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase
18 secondary outcomes
Response Rate in Plasma Glucose Level
Time frame: at Month 6 (M6), Month 12 (M12)
Response Rate in Pulse Rate
Time frame: at baseline, M3, M6, M12
Response Rate in Hematocrit Levels
Time frame: M3, M6, M12
Insulin Levels During OGTT
Time frame: M3, M6, M12
Glucagon Levels During OGTT
Time frame: M3, M6, M12
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
Time frame: M3, M6, M12
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
Time frame: M3, M6, M12
Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)
Time frame: M3, M6, M12
Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
Time frame: M3, M6, M8
Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
Time frame: M3, M6, M12
Patient Global Assessment at the End of Months 3, 6 and 12
Time frame: M3, M6, M12
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection
Time frame: M1 to M3
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection
Time frame: M1 to M3
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection
Time frame: M1 to M3
Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)
Time frame: M4 to M6
Summary of LAR PK Parameters by Dose
Time frame: M4 to M6
Pasireotide Concentrations in LAR Phase
Time frame: M7 to M12
LAR PK Parameter: Ctrough - at Steady State (ss) by Dose
Time frame: M4 to M12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dumping Syndrome
Active, not recruiting
Feasibility Study of Middle Segmental Gastrectomy (MSG) for Gastric Cancer.
Gastric Cancer, Gastric Adenocarcinoma
RecruitingObservational study
Dumping Syndrome After Esophagectomy
Esophagectomy, Dumping Syndrome
Recruiting
Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
Dumping Syndrome, Post-bariatric Hypoglycemia
Recruiting
Dumping Syndrome and Esophageal Atresia
Oesophageal Atresia, Dumping Syndrome
Active, not recruiting
Comparing Dumping Symptoms and Quality of Life 6 Months After Sleeve Gastrectomy With or Without Transit Bipartition in Adults With Obesity
Obesity, Morbid Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOM230 in people with Dumping Syndrome, run by Novartis Pharmaceuticals at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Belgium, France, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate in Plasma Glucose Level (time frame: at Month 3 (M3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.